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A-dec 54.1076.00

by A-Dec, Inc.

A-dec 54.1076.00 is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K251811 on 25 Aug 2025 and listed in FDA GUDID since 19 Feb 2026 (UDI-DI 10194665008550), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251811

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10194665008550 UDI-DI Date19 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251811 Date25 Aug 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251811 decided 25 Aug 2025 Active
  • FDA GUDID UDI-DI 10194665008550 listed 19 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251811
  2. Listed FDA GUDID 10194665008550

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
A-dec
Generic name
Dental surgical power tool motorized handpiece/set, electric
Model / Ref / Catalog
54.1076.00
Primary DI / UDI-DI
10194665008550
510(k) Number
FDA product code
EBW, EKX, LQY
GMDN term
Dental surgical power tool motorized handpiece/set, electric
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K251811)

and 3 more cleared under K251811

Similar devices

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

Other devices from A-Dec, Inc.

  • A-dec 54.1073.00

    Class I

  • A-dec 54.0924.01

    Class I

  • A-dec 54.1074.01

    Class I

  • A-dec 54.1073.01

    Class I

See all devices from A-Dec, Inc. →

Properties

  • Sterilise before use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)